MAUDE Adverse Event Report: BIOMET 3I 3I T3® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Model Number	BOSS485
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Customer reported that the implant looked fractured at the apex on the x-ray but did not have any additional event information.The implant was placed prior to covid but when they removed it, they were easily able to back it out an they believe it was not fully integrated.
Additional Manufacturer Narrative
The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: investigation type codes were added: 3331, 4109, 4110 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67.H10: narrative/data was updated.An osseotite® implant 3.75 x 13mm (boss485) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage.No fracture or damage has been identified.No malfunction.X-ray images were provided by the customer.The x-ray images shows the product, however no fractures identified as well as no fractures inspected to the product.Dhr review was completed for the subject lot number (2019031297).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019031297) for similar event (complaint category keyword: dental : functional : fracture : implant) and no other complaint was identified.December post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction did not occur and the reported event was unconfirmed.
Event or Problem Description
No additional event information at the time of this report.

• Brand Name: 3I T3® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12590106
• Report Number: 0001038806-2021-01899
• Device Sequence Number: 11686241
• Product Code: DZE
• UDI-Device Identifier: 00844868028864
• UDI-Public: (01)00844868028864(17)240402(10)2019031297
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/02/2024
• Device Model Number: BOSS485
• Device Catalogue Number: BOSS485
• Device Lot Number: 2019031297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female